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The SOMATICS collaborative: Introduction to a National Institute on Drug Abuse cooperative study of pharmacotherapy for opioid treatment in criminal justice settings.

ABSTRACT: Among the nearly 750,000 inmates in U.S. jails, 12% report using opioids regularly, 8% report use in the month prior to their offense, and 4% report use at the time of their offense. Although ample evidence exists that medications effectively treat Opiate Use Disorder (OUD) in the community, strong evidence is lacking in jail settings. The general lack of medications for OUD in jail settings may place persons suffering from OUD at high risk for relapse to drug use and overdose following release from jail.The three study sites in this collaborative are pooling data for secondary analyses from three open-label randomized effectiveness trials comparing: (1) the initiation of extended-release naltrexone [XR-NTX] in Sites 1 and 2 and interim methadone in Site 3 with enhanced treatment-as usual (ETAU); (2) the additional benefit of patient navigation plus medications at Sites 2 and 3 vs. medication alone vs. ETAU. Participants are adults with OUD incarcerated in jail and transitioning to the community.We describe the rationale, specific aims, and designs of three separate studies harmonized to enhance their scientific yield to investigate how to best prevent jail inmates from relapsing to opioid use and associated problems as they transition back to the community.Conducting drug abuse research during incarceration is challenging and study designs with data harmonization across different sites can increase the potential value of research to develop effective treatments for individuals in jail with OUD.

SUBMITTER: Chandler RK

PROVIDER: S-EPMC5454801 | biostudies-literature | 2016 May

REPOSITORIES: biostudies-literature

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The SOMATICS collaborative: Introduction to a National Institute on Drug Abuse cooperative study of pharmacotherapy for opioid treatment in criminal justice settings.

Chandler Redonna K RK Finger Matthew S MS Farabee David D Schwartz Robert P RP Condon Timothy T Dunlap Laura J LJ Zarkin Gary A GA McCollister Kathryn K McDonald Ryan D RD Laska Eugene E Bennett David D Kelly Sharon M SM Hillhouse Maureen M Mitchell Shannon G SG O'Grady Kevin E KE Lee Joshua D JD

Contemporary clinical trials 20160511

<h4>Background</h4>Among the nearly 750,000 inmates in U.S. jails, 12% report using opioids regularly, 8% report use in the month prior to their offense, and 4% report use at the time of their offense. Although ample evidence exists that medications effectively treat Opiate Use Disorder (OUD) in the community, strong evidence is lacking in jail settings. The general lack of medications for OUD in jail settings may place persons suffering from OUD at high risk for relapse to drug use and overdose ...[more]

PMID: 27180088

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Project description:BackgroundExtended-release naltrexone, a sustained-release monthly injectable formulation of the full mu-opioid receptor antagonist, is effective for the prevention of relapse to opioid dependence. Data supporting its effectiveness in U.S. criminal justice populations are limited.MethodsIn this five-site, open-label, randomized trial, we compared a 24-week course of extended-release naltrexone (Vivitrol) with usual treatment, consisting of brief counseling and referrals for community treatment programs, for the prevention of opioid relapse among adult criminal justice offenders (i.e., persons involved in the U.S. criminal justice system) who had a history of opioid dependence and a preference for opioid-free rather than opioid maintenance treatments and who were abstinent from opioids at the time of randomization. The primary outcome was the time to an opioid-relapse event, which was defined as 10 or more days of opioid use in a 28-day period as assessed by self-report or by testing of urine samples obtained every 2 weeks; a positive or missing sample was computed as 5 days of opioid use. Post-treatment follow-up occurred at weeks 27, 52, and 78.ResultsA total of 153 participants were assigned to extended-release naltrexone and 155 to usual treatment. During the 24-week treatment phase, participants assigned to extended-release naltrexone had a longer median time to relapse than did those assigned to usual treatment (10.5 vs. 5.0 weeks, P<0.001; hazard ratio, 0.49; 95% confidence interval [CI], 0.36 to 0.68), a lower rate of relapse (43% vs. 64% of participants, P<0.001; odds ratio, 0.43; 95% CI, 0.28 to 0.65), and a higher rate of opioid-negative urine samples (74% vs. 56%, P<0.001; odds ratio, 2.30; 95% CI, 1.48 to 3.54). At week 78 (approximately 1 year after the end of the treatment phase), rates of opioid-negative urine samples were equal (46% in each group, P=0.91). The rates of other prespecified secondary outcome measures--self-reported cocaine, alcohol, and intravenous drug use, unsafe sex, and reincarceration--were not significantly lower with extended-release naltrexone than with usual treatment. Over the total 78 weeks observed, there were no overdose events in the extended-release naltrexone group and seven in the usual-treatment group (P=0.02).ConclusionsIn this trial involving criminal justice offenders, extended-release naltrexone was associated with a rate of opioid relapse that was lower than that with usual treatment. Opioid-use prevention effects waned after treatment discontinuation. (Funded by the National Institute on Drug Abuse; ClinicalTrials.gov number, NCT00781898.).

Project description:ImportanceResponding to the opioid crisis requires tools to identify individuals at risk of overdose. Given the expansion of illicit opioid deaths, it is essential to consider risk factors across multiple service systems.ObjectiveTo develop a predictive risk model to identify opioid overdose using linked clinical and criminal justice data.Design, setting, and participantsA cross-sectional sample was created using 2015 data from 4 Maryland databases: all-payer hospital discharges, the prescription drug monitoring program (PDMP), public-sector specialty behavioral treatment, and criminal justice records for property or drug-associated offenses. Maryland adults aged 18 to 80 years with records in any of 4 databases were included, excluding individuals who died in 2015 or had a non-Maryland zip code. Logistic regression models were estimated separately for risk of fatal and nonfatal opioid overdose in 2016. Model performance was assessed using bootstrapping. Data analysis took place from February 2018 to November 2019.ExposuresControlled substance prescription fills and hospital, specialty behavioral health, or criminal justice encounters.Main outcomes and measuresFatal opioid overdose defined by the state medical examiner and 1 or more nonfatal overdoses treated in Maryland hospitals during 2016.ResultsThere were 2 294 707 total individuals in the sample, of whom 42.3% were male (n = 970 019) and 53.0% were younger than 50 years (647 083 [28.2%] aged 18-34 years and 568 160 [24.8%] aged 35-49 years). In 2016, 1204 individuals (0.05%) in the sample experienced fatal opioid overdose and 8430 (0.37%) experienced nonfatal opioid overdose. In adjusted analysis, the factors mostly strongly associated with fatal overdose were male sex (odds ratio [OR], 2.40 [95% CI, 2.08-2.76]), diagnosis of opioid use disorder in a hospital (OR, 2.93 [95% CI, 2.17-3.80]), release from prison in 2015 (OR, 4.23 [95% CI, 2.10-7.11]), and receiving opioid addiction treatment with medication (OR, 2.81 [95% CI, 2.20-3.86]). Similar associations were found for nonfatal overdose. The area under the curve for fatal overdose was 0.82 for a model with hospital variables, 0.86 for a model with both PDMP and hospital variables, and 0.89 for a model that further added behavioral health and criminal justice variables. For nonfatal overdose, the area under the curve using all variables was 0.85.Conclusions and relevanceIn this analysis, fatal and nonfatal opioid overdose could be accurately predicted with linked administrative databases. Hospital encounter data had higher predictive utility than PDMP data. Model performance was meaningfully improved by adding PDMP records. Predictive models using linked databases can be used to target large-scale public health programs.

Project description:Abstract Background The overlap between justice system involvement and drug use is well‐documented. Justice‐involved people who misuse opioids are at high risk for relapse and criminal recidivism. Criminal justice policymakers consider opioid‐specific medication‐assisted therapies (MATs) one approach for improving outcomes for this population. More research is needed that explores the impacts of opioid‐specific MATs for justice‐involved people. Objectives This study sought to assess the effects of opioid‐specific MAT for reducing the frequency and likelihood of criminal justice and overdose outcomes for current or formerly justice‐involved individuals. Search Methods Records were searched between May 7, 2021 and June 23, 2021. We searched a total of sixteen proprietary and open access databases that included access to gray literature and conference proceedings. The bibliographies of included studies and relevant reviews were also searched. Selection Criteria Studies were eligible for inclusion in the review if they: (a) assessed the effects of opioid‐specific MATs on individual‐level criminal justice or overdose outcomes; included (b) a current or formerly justice‐involved sample; and (c) a randomized or strong quasi‐experimental design; and c) were published in English between January 1, 1960 and October 31, 2020. Data Collection and Analysis We used the standard methodological procedures as expected by The Campbell Collaboration. Main Results Twenty studies were included, representing 30,119 participants. The overall risk of bias for the experimental studies ranged from “some” to “high” and for quasi‐experimental studies ranged from “moderate” to “serious.” As such, findings must be interpreted against the backdrop of less‐than‐ideal methodological contexts. Of the 20 included studies, 16 included outcomes that were meta‐analyzed using mean log odds ratios (which were reported as mean odds ratios). Mean effects were nonsignificant for reincarceration (odds ratio [OR] = 0.93 [0.68, 1.26], SE = .16), rearrest (OR = 1.47 [0.70, 3.07], SE = 0.38), and fatal overdose (OR = 0.82 [0.56, 1.21], SE = 0.20). For nonfatal overdose, the average effect was significant (OR = 0.41 [0.18, 0.91], SE = 0.41, p < 0.05), suggesting that those receiving MAT had nearly 60% reduced odds of a nonfatal overdose. Implications for Policy, Practice, and Research The current review supports some utility for adopting MAT for the treatment of justice‐involved people with opioid addiction, however, more studies that employ rigorous methodologies are needed. Researchers should work with agencies to improve adherence to medication regimens, study design, and collect more detailed information on participants, their criminal and substance use histories, onset, and severity. This would help clarify whether treatment and control groups are indeed comparable and provide better insight into the potential reasons for participant dropout, treatment failure, and the occurrence of recidivism or overdose. Outcomes should be assessed in multiple ways, if possible (e.g., self‐report and official record), as reliance on official data alone may undercount participants' degree of criminal involvement.

Project description:AIMS:To compare long-term criminal justice outcomes among opioid-dependent individuals randomized to receive buprenorphine or methadone. DESIGN, SETTING AND PARTICIPANTS:A 5-year follow-up was conducted in 2011-14 of 303 opioid-dependent participants entering three opioid treatment programs in California, USA in 2006-09 and randomized to receive either buprenorphine/naloxone or methadone. INTERVENTION AND COMPARATOR:Participants received buprenorphine/naloxone (BUP; n = 179) or methadone (MET; n = 124) for 24 weeks and then were tapered off their treatment over ≤ 8 weeks or referred for ongoing clinical treatment. Midway through the study, the randomization scheme was switched from 1 : 1 BUP : MET to 2 : 1 because of higher dropout in the BUP arm. MEASUREMENTS:Study outcomes included arrests and self-reported incarceration. Predictors included randomization condition (buprenorphine versus methadone), age, gender, race/ethnicity, use of cocaine, drug injection in the 30 days prior to baseline and study site. Treatment status (buprenorphine, methadone, none) during follow-up was included as a time-varying covariate. FINDINGS:There was no significant difference by randomization condition in the proportion arrested (buprenorphine: 55.3%, methadone: 54.0%) or incarcerated (40.9%, 47.3%) during follow-up. Among methadone-randomized individuals, arrest was less likely with methadone treatment (0.50, 0.35-0.72) during follow-up (relative to no treatment) and switching to buprenorphine had a lower likelihood of arrest than those receiving no treatment (0.39, 0.18-0.87). Among buprenorphine-randomized individuals, arrest was less likely with receipt of buprenorphine (0.49, 0.33-0.75) during follow-up and switching to methadone had a similar likelihood of arrest as methadone-randomized individuals receiving no treatment. Likelihood of arrest was also negatively associated with older age (0.98, 0.96-1.00); it was positively associated with Hispanic ethnicity (1.63, 1.04-2.56), cocaine use (2.00, 1.33-3.03), injection drug use (2.19, 1.26-3.83), and study site. CONCLUSIONS:In a US sample of people treated for opioid use disorder, continued treatment with either buprenorphine or methadone was associated with a reduction in arrests relative to no treatment. Cocaine use, injection drug use, Hispanic ethnicity and younger age were associated with higher likelihood of arrest.

Dataset Information

The SOMATICS collaborative: Introduction to a National Institute on Drug Abuse cooperative study of pharmacotherapy for opioid treatment in criminal justice settings.

Publications

The SOMATICS collaborative: Introduction to a National Institute on Drug Abuse cooperative study of pharmacotherapy for opioid treatment in criminal justice settings.

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